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Recruiting Phase 2 / Phase 3

A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

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About this study

This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.

Condition
Non-small Cell Lung Cancer
Tested
BL-B01D1, Osimertinib, Carboplatin, Pemetrexed, Cisplatin
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Non-small Cell Lung Cancer
  • Voluntarily sign informed consent and agree to comply with the protocol requirements;
  • Aged ≥18 years and ≤75 years, regardless of gender;
  • Expected survival time ≥3 months;
  • Patients with non-small cell lung cancer;
  • One of the EGFR sensitive mutation types detected in the tumor tissue;
  • Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples;
  • Undergo pulmonary function testing within 28 days prior to the first dose;
  • ECOG performance status score of 0 or 1;
  • No severe cardiac dysfunction;
  • Organ function levels must meet the required criteria;
  • Urine protein ≤1+ or \<1000 mg/24h;
  • For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be lactating; all enrolled trial participants must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.

Exclusion 25

  • SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;
  • Trial participants who subsequently receive only segmentectomy or wedge resection;
  • Trial participants deemed surgically inoperable by the study center's surgical evaluation;
  • Undergoing major surgery within 4 weeks prior to the first dose, among others;
  • Previous receipt of systemic anti-tumor therapy for non-small cell lung cancer other than that for this study, among others;
  • Receiving long-term systemic corticosteroid therapy with prednisone \>10 mg/day within 2 weeks prior to randomization, among others;
  • History of severe heart disease or cerebrovascular disease;
  • Prolonged QTc interval, complete left bundle branch block, etc.;
  • Any thrombotic event within 6 months prior to screening;
  • Trial participants with known or suspected interstitial lung disease, among others;
  • Diagnosis of active malignant tumors within 5 years prior to study randomization;
  • Hypertension inadequately controlled by two antihypertensive medications;
  • Trial participants with poorly controlled blood glucose;
  • Severe infection occurring within 4 weeks prior to study randomization, among others;
  • Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;
  • Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
  • Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;
  • Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
  • Inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, etc.;
  • History of allergy to the investigational drug, etc.;
  • History of solid organ transplantation, autologous or allogeneic stem cell transplantation;
  • Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;
  • History of severe neurological or psychiatric disorders;
  • Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;
  • Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.

Where

2 sites, 2 recruiting

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Recruiting

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.